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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN06101946 |
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Date of registration:
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14/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An evaluation of the Cares of Life Project (CoLP): Fundamentally improving mental health services for Black people in Southwark
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Scientific title:
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Date of first enrolment:
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01/06/2002 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN06101946 |
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Study type:
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Interventional |
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Study design:
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A randomised controlled trial. (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Graham
Thornicroft |
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Address:
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Health Services and Population Research
Institute of Psychiatry
De Crespigny Park
SE5 8AF
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Individuals who were referred to the service were included in the study if they met all of the following criteria:
1. Resident of the London Borough of Southwark
2. Of Black African origin (Black African individuals born in sub-Saharan Africa or born in the UK with at least one parent of sub-Saharan decent) or Black Caribbean origin (Black patients born in the Caribbean or born in the UK with at least one parent of Caribbean decent).
3. Scored positive for symptoms on the World Health Organisation Mental Health Checklist for Anxiety and Depression indicating a diagnosis of clinical depression (ICD-10 codes F32, F33.0 - F33.2) and/or anxiety (F40, F41.1, F41.2)
4. Consented to being randomised
Exclusion criteria: 1. Non-English speaking
2. Resident of another borough
3. Did not score positive for symptoms on the WHO checklist for anxiety and depression
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety and /or depression
Mental and Behavioural Disorders
Anxiety, depression
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Intervention(s)
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The experimental group had rapid access to Community Health Workers who delivered a needs-led package of care comprising psychological therapies (cognitive behavioural therapy, Brief Solution Focused Therapy), health education, advocacy, mentoring and some physical health investigations (blood pressure and blood sugar testing). The control group had 'standard access.' Individuals were followed up after 3 months of receiving the intervention.
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Primary Outcome(s)
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Psychological well-being and general functioning were rated using the following at baseline and 3-month follow-up:
1. General Health Questionnaire (GHQ-28)
2. Short Form 36 (SF-36)
3. Global Assessment of Functioning (GAF)
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Secondary Outcome(s)
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1. Perceived access to and cultural sensitivity of mental health services, rated using the Accessibility and Cultural Sensitivity Schedule (ACCeSS), assessed at baseline and 3-month follow-up
2. Satisfaction with mental health services rated using the Treatment Perceptions Questionnaire (TPQ) at 3-month follow-up
3. Trust in mental health services examined using the TRUST semi-structured interview schedule at 3-month follow-up
4. Cost of service use (CSRI) assessed at baseline and 3-month follow-up
5. The social context of mental health rated using the Shortened Life Events and Difficulties Schedule (SLEDS) at baseline and 3-month follow-up
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Secondary ID(s)
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N0042132131
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Source(s) of Monetary Support
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Guy's and St Thomas' Charitable Foundation (Grant code GO11019DF) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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